Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid

This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Stapokibart in subjects with Moderate to Severe Bullous Pemphigoid.

Inclusion Criteria:

• Ability to understand the study content and voluntarily sign the Informed Consent Form (ICF).
• Aged between 18 and 90 years, inclusive, regardless of gender.
• Confirmed diagnosis of bullous pemphigoid prior to randomization.
• Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥ 24 points at the screening visit and at randomization.
• Weekly average of the Pruritus Numerical Rating Scale (NRS) score ≥ 4 points at randomization.
• Karnofsky Performance Status score ≥50% at the screening visit.

Exclusion Criteria:

• Diagnosis of other forms of pemphigoid or other autoimmune blistering diseases.
• Presence of other active skin comorbidities that may interfere with the study evaluations, apart from bullous pemphigoid.
• Insufficient washout period for prior treatments.
• Any condition that, in the opinion of the investigator, would preclude the subject's participation in the study.